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Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease:baseline data and statistical analysis plan for the Lacunar Intervention Trial-2(LACI-2)(ISRCTN14911850)

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Stroke & Vascular Neurology 2023年第2期8卷 134-143页

作者： Philip M Bath Iris Mhlanga Lisa J Woodhouse Fergus Doubal Katherine Oatey Alan A Montgomery Joanna M Wardlaw LACI-Trial Investigators Stroke trials unit University of NottinghamNottinghamUK Centre for clinical Brain Sciences UK Dementia Research Institute CentreUniversity of EdinburghEdinburghUK Edinburgh clinical trials unit University of EdinburghEdinburghUK Nottingham clinical trials unit University of NottinghamNottinghamUK

Background Cerebral small vessel disease(SVD)causes lacunar strokes(25%of all ischaemic strokes),physical frailty and cognitive impairment and vascular and mixed *** is no specific treatment to prevent progression of *** The LACunar Intervention Trial-2 is an investigator-initiated prospective randomised open-label blinded-endpoint phase II feasibility study assessing cilostazol and isosorbide mononitrate for preventing SVD *** aimed to recruit 400 patients with clinically evident lacunar ischaemic stroke and randomised to cilostazol,isosorbide mononitrate,both or neither,in addition to guideline secondary ischaemic stroke prevention,in a partial factorial *** primary outcome is feasibility of recruitment and adherence to medication;key secondary outcomes include:drug tolerability;recurrent vascular events,cognition and function at 1 year after randomisation;and safety(bleeding,falls,death).Data are number(%)and median(IQR).Results The trial commenced on 5 February 2018 and ceased recruitment on 31 May 2021 with 363 patients randomised,with the following baseline characteristics:average age 64(56.0,72.0)years,female 112(30.9%),stroke onset to randomisation 79.0(27.0,244.0)days,hypertension 267(73.6%),median blood pressures 143.0(130.0,157.0)/83.0(75.0,90.0)mm Hg,current smokers 67(18.5%),educationally achieved end of school examinations(A-level)or higher 118(32.5%),modified Rankin scale 1.0(0.0,1.0),National Institutes Health stroke scale 1.0(1.4),Montreal Cognitive Assessment 26.0(23.0,28.0)and total SVD score on brain imaging 1.0(0.0,2.0).This publication summarises the baseline data and presents the statistical analysis *** The trial is currently in follow-up which will complete on 31 May 2022 with results expected in October *** registration number ISRCTN14911850.

关键词： nitrate initiated prevention

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Thermal ablation in colorectal liver metastases-the paradox of equipoise

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Hepatobiliary Surgery and Nutrition 2021年第2期10卷 276-278页

作者： Nalinie Joharatnam-Hogan Khurum Khan Department of Gastrointestinal Oncology University College London Hospitals NHS Foundation TrustLondonUK mrc clinical trials unit at ucl LondonUK ucl Cancer Institute LondonUK Department of Gastrointestinal Oncology North Middlesex University HospitalLondonUK

Approximately 25%of individuals with colorectal cancer(CRC)present with metastatic disease,and it is estimated that throughout the course of the disease,up to 50%of individuals may develop liver metastases,the majority of which are unresectable(1).However,thermal ablation is a treatment modality increasingly used to manage individuals with liver *** Takahashi et *** a comprehensive review of the various approaches to thermal ablation and summarised the recent evidence demonstrating an associated survival benefit supporting its use in the management of metastatic CRC(mCRC)(2).It is however critical to analyse the studies evaluated to ensure the strength of the evidence presented.

关键词： colorectal metastases liver

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A Measure for Assessing Functions of Time-Varying Effects in Survival Analysis

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Open Journal of Statistics 2014年第11期4卷 977-998页

作者： Anika Buchholz Willi Sauerbrei Patrick Royston Center for Medical Biometry and Medical Informatics Medical Center - University of Freiburg Freiburg Germany mrc clinical trials unit at University College London London UK

A standard approach for analyses of survival data is the Cox proportional hazards model. It assumes that covariate effects are constant over time, i.e. that the hazards are proportional. With longer follow-up times, though, the effect of a variable often gets weaker and the proportional hazards (PH) assumption is violated. In the last years, several approaches have been proposed to detect and model such time-varying effects. However, comparison and evaluation of the various approaches is difficult. A suitable measure is needed that quantifies the difference between time-varying effects and enables judgement about which method is best, i.e. which estimate is closest to the true effect. In this paper we adapt a measure proposed for the area between smoothed curves of exposure to time-varying effects. This measure is based on the weighted area between curves of time-varying effects relative to the area under a reference function that represents the true effect. We introduce several weighting schemes and demonstrate the application and performance of this new measure in a real-life data set and a simulation study.

关键词： Cox Model Measure of Distance Survival Analysis Time-Varying Effects

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Therapies for Tau-associated neurodegenerative disorders:targeting molecules,synapses,and cells

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Neural Regeneration Research 2023年第12期18卷 2633-2637页

作者： Miranda Robbins mrc Laboratory of Molecular Biology Cambridge Biomedical CampusFrancis Crick AveTrumpingtonCambridgeUKUniversity of CambridgeDepartment of ZoologyCambridgeUK

Advances in experimental and computational technologies continue to grow rapidly to provide novel avenues for the treatment of neurodegenerative disorders. Despite this, there remain only a handful of drugs that have shown success in late-stage clinical trials for Tau-associated neurodegenerative disorders. The most commonly prescribed treatments are symptomatic treatments such as cholinesterase inhibitors and N-methyl-D-aspartate receptor blockers that were approved for use in Alzheimer's disease. As diagnostic screening can detect disorders at earlier time points, the field needs pre-symptomatic treatments that can prevent, or significantly delay the progression of these disorders(Koychev et al., 2019). These approaches may be different from late-stage treatments that may help to ameliorate symptoms and slow progression once symptoms have become more advanced should early diagnostic screening fail. This mini-review will highlight five key avenues of academic and industrial research for identifying therapeutic strategies to treat Tau-associated neurodegenerative disorders. These avenues include investigating(1) the broad class of chemicals termed “small molecules”;(2) adaptive immunity through both passive and active antibody treatments;(3) innate immunity with an emphasis on microglial modulation;(4) synaptic compartments with the view that Tau-associated neurodegenerative disorders are synaptopathies. Although this mini-review will focus on Alzheimer's disease due to its prevalence, it will also argue the need to target other tauopathies, as through understanding Alzheimer's disease as a Tau-associated neurodegenerative disorder, we may be able to generalize treatment options. For this reason, added detail linking back specifically to Tau protein as a direct therapeutic target will be added to each topic.

关键词： Alzheimer's disease antibody frontotemporal dementia immunotherapy small molecules synapses tau therapeutics

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clinical management of cerebral small vessel disease:a call for a holistic approach

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Chinese Medical Journal 2021年第2期134卷 127-142页

作者： Una Clancy Jason P.Appleton Carmen Arteaga Fergus N.Doubal Philip M.Bath Joanna M.Wardlaw Centre for clinical Brain Sciences and UK Dementia Research InstituteUniversity of EdinburghChancellor's Building49 Little France CrescentEdinburghEH164SPUK Stroke trials unit Division of Clinical NeuroscienceUniversity of NottinghamNottingham NG51PBUK Stroke University Hospitals Birmingham NHS Foundation TrustMindelsohn WayEdgbastonBirmingham B152GWUK Stroke Nottingham University Hospitals NHS TrustNottingham NG51PBUK.

Cerebral small vessel disease(SVD)is a common global brain disease that causes cognitive impairment,ischemic or hemorrhagic stroke,problems with mobility,and neuropsychiatric *** brain damage,seen as focal white and deep grey matter lesions on brain magnetic resonance imaging(MRI)or computed tomography(CT),typically accumulates"covertly"and may reach an advanced state before being detected incidentally on brain scanning or causing *** have typically presented to different clinical services or been recruited into research focused on one clinical manifestation,perhaps explaining a lack of awareness,until recently,of the full range and complexity of *** this review,we discuss the varied clinical presentations,established and emerging risk factors,relationship to SVD features on MRI or CT,and the current state of knowledge on the effectiveness of a wide range of pharmacological and lifestyle *** core message is that effective assessment and clinical management of patients with SVD,as well as future advances in diagnosis,care,and treatment,will require a more"joined-up"’*** approach should integrate clinical expertise in stroke neurology,cognitive,and physical *** requires more clinical trials in order to improve pharmacological interventions,lifestyle and dietary modifications.A deeper understanding of the pathophysiology of SVD is required to steer the identification of novel *** essential prerequisite to accelerating clinical trials is to improve the consistency,and standardization of clinical,cognitive and neuroimaging endpoints.

关键词： Dementia Magnetic resonance imaging Mild cognitive impairment Risk factors Small vessel disease Stroke Symptoms Treatment

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Hepatocellular carcinoma-specific immunotherapy with synthesized α1,3-galactosyl epitope-pulsed dendritic cells and cytokine-induced killer cells

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World Journal of Gastroenterology 2011年第48期17卷 5260-5266页

作者： Ying Qiu Ming-Bao Xu Mark M Yun Yi-Zhong Wang Rui-Ming Zhang Xing-Kai Meng Xiao-Hui Ou-Yang Sheng Yun The First Teaching Hospital Inner Mongolia Medical College Huhhot 010050 Inner Mongolia Autonomous Region China The Armed Police General Hospital Beijing100036 China Medical School of ucl London WC1E 6BTUnited Kingdom Aerospace Medical College Peking University Beijing 100049 China Department of clinical Sciences King＇s College Hospital London SE5 9NU United Kingdom clinical Sciences Centre MRC HammersmithHospital Campus London W12 0NN United Kingdom

AIM: To evaluate the safety and clinical efficacy of a new immunotherapy using both α-Gal epitope-pulsed dendritic cells (DCs) and cytokine-induced killer ***: Freshly collected hepatocellular carcinoma(HCC) tumor tissues were incubated with a mixture of neuraminidase and recombinant α1,3-galactosyltransferase (α1,3GT) to synthesize α-Gal epitopes on carbohydrate chains of the glycoproteins of tumor membranes. The subsequent incubation of the processed membranes in the presence of human natural anti-Gal IgG resulted in the effective phagocytosis to the tumor membrane by DCs. Eighteen patients aged 38-78 years with stage Ⅲ primary HCC were randomLy chosen for the study; 9 patients served as controls, and 9 patients were enrolled in the study ***: The evaluation demonstrated that the procedure was safe; no serious side effects or autoimmune diseases were observed. The therapy significantly prolonged the survival of treated patients as compared with the controls (17.1 ± 2.01 mo vs 10.1 ± 4.5 mo,P = 0.00121). After treatment, all patients in the study group had positive delayed hyper sensitivity and robust systemic cytotoxicity in response to tumor lysate as measured by interferon-γ-expression in peripheral blood mononuclear cells using enzyme-linked immunosorbent spot assay. They also displayed increased numbers of CD8-, CD45RO-and CD56-positive cells in the peripheral blood and decreased α-fetoprotein level in the ***: This new tumor-specific immunotherapy is safe, effective and has a great potential for the treatment of tumors.

关键词： Hepatocellular carcinoma α-Gal epitope Dendritic cell Tumor-associated antigen Dendritic cell-activated cytokine-induced killer cell

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采用全淋巴细胞计数确定何时开始对HIV感染患儿进行抗逆转录病毒治疗:一项纵向临床资料的荟萃分析

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世界核心医学期刊文摘（儿科学分册） 2006年第4期2卷 3-4页

作者： Dunn D 张振 mrc clinical trials unit 222 Euston Road London NW1 2DA United Kingdom.Dr

Background: Total lymphocyte count has been proposed as an alternative to the percentage of CD4+ T-cells to indicate when antiretroviral therapy should be started in children with HIV in resource-poor settings. We aimed to assess thresholds of total lymphocyte count at which antiretroviral therapy should be considered, and compared monitoring of total lymphocyte count with monitoring of CD4- cell percentage. Methods: Longitudinal data on 3917 children with HIV infection were pooled from observational and randomised studies in Europe and the USA. The 12- month risks of death and AIDS by most recent total lymphocyte count and age were estimated by parametric survival models, based on measurements before antiretroviral therapy or during zidovudine monotherapy. Risks were derived and compared at thresholds of total lymphocyte count and CD4- cell percentage for starting antiretroviral therapy recommended in WHO 2003 guidelines. Findings: Total lymphocyte count was a powerful predictor of the risk of disease progression despite a weak correlation with CD4- cell percentage (r=0.08- 0.19 dependent on age). For children older than 2 years, the 12- month risk of death and AIDS increased sharply at values less than 1500- 2000 cells per μ L, with little trend at higher values. Younger children had higher risks and total lymphocyte count was less prognostic. Mortality risk was substantially higher at thresholds of total lymphocyte count recommended by WHO than at corresponding thresholds of CD4- cell percentage. When the markers were compared at the threshold values at which mortality risks were about equal, total lymphocyte count was as effective as CD4- cell percentage for identifying children before death, but resulted in an earlier start of antiretroviral therapy. Interpretation: In this population, total lymphocyte count was a strong predictor of short-term disease progression, being only marginally less predictive than CD4- cell percentage. Confirmatory studies in resource

关键词： HIV感染淋巴细胞计数荟萃分析临床资料叠氮脱氧胸苷细胞百分数抗逆转录病毒治疗开始时间

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Sociodemographic profile and social support for post-stroke depression in Kinshasa: A rehabilitation based cross-sectional study

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Open Journal of Epidemiology 2013年第3期3卷 111-117页

作者： Magloire Nkosi Mpembi Samuel Mampunza ma Miezi André Peeters Marie-Pierre de Partz Sévérine Henrard Victoria Kubuta Massamba Roland Nengi Nsam Thierry Matonda ma Nzuzi Jean Macq Vincent Dubois Eric Constant Centre Neuro PsychoPathologique Université de Kinshasa (UNIKIN) Kinshasa Congo Cliniques Universitaires Saint Luc Université Catholique de Louvain (UCL) Brussels Belgium Institut de Recherché Santé et Société Université Catholique de Louvain (UCL) Brussels Belgium Research Center in Epidemiology Biostatistics and Clinical Trials School of Public Health Université Libre de Bruxelles Brussels Belgium

The World Health Organization has highlighted the emergence of non-communicable chronic diseases, including stroke, in developing countries. As a cause of death, stroke ranks first in Africa. Stroke is the foremost cause of neuropsychiatric disease, including post-stroke depression (PSD) which is a very common disease. Surveys of this condition in Congolese pa tients are virtually non-existent. The objectives of this study were to assess the prevalence of PSD in Congolese patients and identify associated sociodemographic factors. Age, sex, address, province of origin, social and professional status, education, religion and consumption habits were chosen as indicators or parameters of interest to be examined in this study. The results of descriptive analyses are presented as frequencies for categorical variables and as mean ± standard deviation for quantitative variables. The association between different variables was assessed using tables of comparisons of proportions and the Chi-square test. Logistic regression was performed to predict the occurrence of PSD. There were more male than female patients. The mean age was 54.67 ± 12.51 years. Nearly 3 fourths of the patients were aged less than 65. The family was the primary source of social support. The majority was satisfied by the social support received from the family. Just over half the study patients (53.6%) had mild to severe depression as assessed by the PHQ9. Univariate analysis and logistic regression indicated a statistically significant association between low educational level and the occurrence of PSD. However, there was no relationship between age, sex or drinking habits and the onset of PSD. The majority of the subjects were satisfied by the social support from their families. Depression was common after stroke with the occurrence of 53.6%. These results highlight the need to investigate, diagnose and treat PSD, which is a risk factor for morbidity and mortality after stroke.

关键词： Stroke Post-Stroke Depression Kinshasa

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多重结局的多元Meta分析和多重治疗的网状Meta分析:原理、概念及实例

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英国医学杂志中文版 2018年第12期21卷 725-735页

作者： Richard D Riley Dan Jackson Georgia Salanti Danielle L Burke Malcolm Price Jamie Kirkham Ian R White 孙至佳(译) 张岩(译) 刘雪晴(译) 杨智荣(校) 孙凤(校) Research Institum for Primary Care and Health Sciences Keele University StaffordshireUK mrc Biestatistics Onit CambridgeUK Institute of Social and Preventive Medicine University of BernSwitzerland University of Ioannina School of Medicine Ioannina Greece Institute of Applied Health Research University of BirminghamUK mrc North West Hub for trials Methodology Research Department of Biostatistics University of LiverpoolLiverpool UK mrc clinical trials unit at ucl London UK 北京大学公共卫生学院流行病与卫生统计学系

英国国家健康与临床优选研究所(NICE)等组织需要对现有研究获得的证据进行整合来指导决策,需要确定关于多重疗效及安全性结局的最佳治疗。但是,相关的研究不一定对所有关注的治疗或结局都进行了直接比较,多元Meta分析及网状Meta分析为... 详细信息

英国国家健康与临床优选研究所(NICE)等组织需要对现有研究获得的证据进行整合来指导决策,需要确定关于多重疗效及安全性结局的最佳治疗。但是,相关的研究不一定对所有关注的治疗或结局都进行了直接比较,多元Meta分析及网状Meta分析为如何确定最佳治疗这一问题提供了思路,该方法不仅考虑了直接证据,还利用了关联或间接的证据。本文中,研究者描述了这些方法学的重要概念及假设,并阐述关联及间接证据如何产生,同时通过图表说明这些证据在涉及多重结局和多重治疗的真实临床案例中如何使用。

关键词：网状Meta分析最佳治疗多重实例临床案例证据研究所安全性

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Mononuclear cell therapy of neonatal hypoxic-ischemic encephalopathy in preclinical versus clinical studies:A systematic analysis of therapeutic efficacy and study design

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Neuroprotection 2023年第2期1卷 143-159页

作者： Alexander M.Scrutton Francesca Ollis Johannes Boltze School of Life Sciences University of WarwickCoventryUK Neurobiology Division MRC Laboratory of Molecular BiologyUniversity of CambridgeCambridgeUK

Background:Hypoxic-ischemic encephalopathy(HIE)is a devastating condition affecting around 8.5 in 1000 newborns *** hypothermia(TH)can reduce mortality and,to a limited extent,disability after ***,there is a need for new and effective treatment ***-based treatments using mononuclear cells(MNCs),which can be sourced from umbilical cord blood,are currently being *** promising preclinical results,there is currently no strong indicator for the clinical efficacy of the *** analysis aimed to provide potential explanations for this ***:A systematic review and meta-analysis were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis *** and clinical studies were retrieved from PubMed,Web of Science,Scopus,and *** using a predefined search strategy.A total of 17 preclinical and 7 clinical studies were *** analyzed overall MNC efficacy in preclinical trials,the methodological quality of preclinical trials,and relevant design features in preclinical versus clinical ***:There was evidence for MNC therapeutic efficacy in preclinical models of *** methodological quality of preclinical studies was not optimal,and statistical design quality was particularly ***,methodological quality was above the standard in other *** were significant differences in preclinical versus clinical study design including the use of TH as a baseline treatment(only in clinical studies)and much higher MNC doses being applied in preclinical ***:Based on the analyzed data,it is unlikely that therapeutic effect size is massively overestimated in preclinical *** is more plausible that the many design differences between preclinical and clinical trials are responsible for the so far lacking proof of the efficacy of MNC treatments in *** preclinical and clinical research is required

关键词： cell therapy hypoxic-ischemic encephalopathy mononuclear cells translational research treatment efficacy

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